FDA 510(k) Application Details - K121590

Device Classification Name	Apparatus, Vestibular Analysis   More FDA Info for this Device
510(K) Number	K121590
Device Name	Apparatus, Vestibular Analysis
Applicant	CAPACITY SPORTS, LLC 2800 PLEASANT HILL SUITE 175 PLEASANT HILL, CA 94523 US Other 510(k) Applications for this Company
Contact	PAMELA M BUCKMAN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2012
Decision Date	09/20/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review